Associate Director, Commercial Manufacturing & Packaging
Job in
Boise, Ada County, Idaho, 83701, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Manufacturing / Production
Regulatory Compliance Specialist, Pharmaceutical Manufacturing
Job Description & How to Apply Below
Associate Director of Commercial Manufacturing overseeing global drug product manufacturing and packaging for rare disease therapies. Objectives include ensuring continuous, compliant supply by managing manufacturing planning, CMO governance, validation, technology transfer, and supply-risk mitigation.
Responsibilities- coordinating manufacturing activities at CMOs
- developing schedules based on sales forecasts
- verifying process qualification
- supporting troubleshooting
- maintaining GMP compliance
- representing manufacturing in due diligence and regulatory interactions
- authoring technical reports
- Bachelor's in Process/Chemical Engineering or related field
- 8+ years leading pharmaceutical manufacturing, including process troubleshooting and optimization
- experience with multiple dosage forms, preferably oral solid dosage
- process validation, project management, risk mitigation, and strong communication
- familiarity with US/EU GMP standards
- complex project management
- international travel (up to 10%)
- biologic or small molecule manufacturing for rare disease therapies
- involvement in regulatory submissions and audits
remote with face-to-face collaboration in San Diego; travel required.
Position Requirements
10+ Years
work experience
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